| Up
2005P-0072:
Withholding of safety information regarding risks of Steven s Johnson
Syndrome and Toxic Epidermal Necrolysis Associated with Ibuprofen
products
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| Document #
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| Received Date
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| Filed
Date
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| Submitter Code
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| Submitter
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| FR
Date
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| FR
Page
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| Comment Date
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| Files
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| Remarks
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| CP1
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| 02/15/2005
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| 02/15/2005
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| Private Industry
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| New York Medical College,
et al
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| Table
of Contents
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| Signature:
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| Roger E. Salisbury, M.D, et
al
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| ACK1
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| 02/15/2005
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| 02/15/2005
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| Federal Government
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| HFA-305 to New York
Medical College, et al
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| pdf
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| Signature:
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| Jennie C. Butler
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| C1
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| 03/03/2005
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| 03/03/2005
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| Private Industry
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| Westchester Burn Center
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| pdf
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| Signature:
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| Roger E Salisbury
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| LET1
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| 08/11/2005
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| 08/11/2005
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| Federal Government
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| HFD-005 to New York
Medical College, et al
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| pdf
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| Signature:
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| Jane A. Axelrad
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| PAV1
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| 06/27/2006
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| 06/27/2006
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| Federal Government
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| FDA/CDER to New York
Medical College,
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| pdf
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| petition is granted
in part and denied in part
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| Signature:
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| Steven K. Galson, M.D., M.P.H.
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Top | Up
Page last updated
July 27, 2006
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